FDA 510(k) Application Details - K960388

Device Classification Name Gauze/Sponge, Internal

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510(K) Number K960388
Device Name Gauze/Sponge, Internal
Applicant DYNAREX CORP.
ONE INTERNATIONAL BLVD.
BREWSTER, NY 10509 US
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Contact JOHN G MOULDEN
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Regulation Number 000.0000

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Classification Product Code EFQ
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Date Received 01/26/1996
Decision Date 04/01/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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